The FDA has handed TaiMed and its partners at Theratechnologies an approval for the first new HIV drug to come along in a decade with a novel mechanism of action.
The drug, to be marketed as Trogarzo (ibalizumab-uiyk), works by binding to the second extracellular domain of the CD4+ T cell receptor, away from other binding sites used by drugs already on the market. That approach allows patients who are becoming resistant to their therapies to add this to the mix before being exposed to a lethal amount of virus.
Taiwan-based TaiMed offered enough data from a mid-stage program to warrant both a breakthrough therapy designation as well as a priority review for this drug, slicing the time needed for an FDA inspection.
For a low profile therapy, this drug is a remarkable trendsetter in many ways. Shanghai-based WuXi Biologics — part of Ge Li’s expansive biopharma empire — will manufacture the drug, and the FDA completed its first-ever inspection and approval of a Chinese manufacturing facility to lay the foundation for the commercial rollout.
“While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” said Jeff Murray, deputy director of the Division of Antiviral Products in the FDA’s CDER. “Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes.”
TaiMed out-licensed the drug to Montreal-based Theratechnologies a couple of years ago in a deal that starts very small. The biotech bagged just a million dollars, initially, with another million due on launch. There’s a few million more in shares for various conditions, and $10 million once annual sales of $200 million are reached in the US. That goes up to a $100 million if they can break the $1 billion mark.
Theratechnologies also agreed to a development milestone for Phase III of $50 million, paid quarterly.
Investors liked the sound of all of it. Theratechnologies’ shares $THERF soared 30% on the news.
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